Venting structure



July 12, 1960 E. M. KATZIN VENTING STRUCTURE Filed March 18, 1957INVENXTOR Eqgaae 1% imizm/ B I hLmM (M ATTORNEYs UnitedjStates Patent2,944,548 7 1C- j P te e 19 VENTING STRUCTURE Eugene M. Katzin, sBaldwin Ave., Newark, NJ.

' Filed Mar. 18, 1957, Ser. No. 646,806

3 Claims. Cl. 128-214) thereby provide an assembly which will assureproperventing of air through the closure regardless'of whether thereceptacle is in an upright or an inverted position;

properly filtered air or other gases being solely enbraced in that flowso that no contamination of the receptacle contents will occur.

Among further objects of the invention are those of. furnishing anassembly which may be economically produced, which will effectivelyfilter the air, or other gas, and render such gas free of bacterialcontamination and will be capable of ready application to and removalfrom a closure, and .which will act in such manner as to preventaccidental injury or death by air embolism. Also,

after a single use, it may be discarded.

With these and other objects in mind, reference is had to the attachedsheet of drawings illustrating practical embodiments of the inventionand in which:

Fig. 1 is a sectional side view of the upper end of a receptacle with aclosure applied thereto and the venting structure mounted thereby;

Fig. 2 is a view similar to Fig. 1 but showing the venting structure insection and the receptacle in inverted position;

Figs. 3, 4 and 5 are sectional side views in enlarged scale showingalternative forms of venting structure; and

Fig. 6 is a perspective view of a cannulasuitable for inclusion in theassembly.

Referring primarily to Figs. 1 and 2, the body of the receptacle orflask has been indicated at 10. Thismember terminates in an open neckportion, the outer edge of which is ordinarily defined by a bead 11. Astopper including a plug 12 and head 13 seals the mouth of thereceptacle by having its plug extending into the bore of the neck withits head overlying and'engaging the surface of the pouring lip definedby bead 11. The stopper is retained against accidental displacement by,for example, a ring 14 conveniently formed of metal. That ring overlapsthe outer surface of head portion ,13 and may have its skirt edges spuninwardly as shown to underlie bead 11. Under these circumstances,removal of the closure from the flask is precluded unless the ring bedestroyed and stripped from its mounted position.

The stopper will be formed with a suitable number of bores, Thus, bores15 and 17 extend inwardly from the plug end of the same. They areprovided with pierceable diagram portions 1 6 and 18. Customarily, thebore 15 may have a smaller diameter, than bore 17. In line with theaxes" of these bores, the surface of head 13 may be provided with marksindicating the zones of the diaphragm or diaphragms. A tube or stalk? 19(Fig. 2) made vof'glass or other suitable material may extend into bore17 and within the receptacle 10 to a point close- 1y spaced from thebase thereof. a It will be understood that the foregoingpresents onepreferred grouping of parts to furnish the seal assembly of a receptacleor flask. However, the structure may be modified in ,numerous respectsin'accordance with the specifications laid down by the manufacturer ofthe equipment; 4

Assuming, however, that an assembly of this general type is present andwith, which the novelventing structure of this invention is to becombined, it is customary to pierce diaphragm portion 16 by a cannula20.This is achieved by simply forcing fthe pointed end ofthe latter throughthe diaphragm; As shown, the piercing action may be continued until thepoint of the cannula extends beyond the inner face ofthe closure. Thecan nula is connected in any suitable. manner with a tube 21. Similarly,a cannula 22' may be introduced through diaphragm 18 and thus extendintothe bore of the .tube 19, if the latter is employed. Both cannula 20and 22 are preferably formed of metal. The lumen of the latter cannulamay emerge asindicated at 23 from the side face of its shank. Attachedto that end of cannula 22 which is opposite its point is a casing 2'4.

Cannula 20 serves to introduce or remove fluids from the'interi'or ofreceptacle 10. Those fluids will ordinarily be blood or serium or plasmaor intravenous nutriments 'or medications such as glucose, saline,distilled water (these in various combinations or concentrations),aswell as intravenous fluids containing amino acids,vitamins, hormones,chemicals, pharmaceuticals, large molecule plastic suspensions, plasmaextenders for fluid volume replacement, blood fractions (albumin,globulin, fibrinogen etc.). The point zone of cannula 20 may be ofstandard typeas illustrated in Figs. 1 or 2, or may embrace any desiredconstruction. It will be appreciated that when either of the cannul-aeare withdrawn, the perforations through diaphragm portions 16 or 18mayas is usually requiredautomatically close so as to again establish aneffective seal for the receptacle. Cannula 22 being usually ofrelatively large diameter, and serving by means of its lumen to providea' vent, it is definitely preferred to employ a needle of the anticoringtype. Therefore, this unit has been shown as involving a piercing pointwith a side opening 23.

This type of needle spreads the stopper diaphragm material (rubber,plastic, etc.) and does not tear or core the stoper. Also, as notedabove, the diaphragm reseals upon withdrawal of the needle therefrom.Additionally, obstruction of the lumen of the cannula by stoppermaterial is prevented. Various forms of end zone may be embodied in thecannula associated with the venting structure. For example, as in Fig.3, the cannula 25 may be provided with an ofiset outer end portion 26.As in Fig. 4, the cannula 27 may have its outer end terminate in animperforate end wall defining the piercing pointand with the end of thelumen lying within the plane of the opposite side wall of the cannula asindicated at 28. The needle shown in Figs. 5 and'6 may embrace 'a body29 with an end zone 30 into which a channel shaped depression 31extends. By such aconstruction, spreading surfaces are furnished which,as the needle penetrates the stopper, prevent the material of thestopper from coring. 7

.Aside from preventing obstruction of the lumen, it is important withliquids or gases in the receptacle, that intact stopper diaphragmprevent contaminationor 7 loss during storage by precluding contactbetweenth'e inside and outside of the container. In the case of thefilling of a receptacle with blood by phlebotomy, any obstruction of airflow can cause positive pressure to build up within the receptacle.Therefore, when the tourniquet on the donors 'armis purposely orinadvertently loosened, the entrapped air may reverse the blood flow andbe forced up through the filling cannula, through the tubing connectingthe donors vein with the flask, and then into the donors veins and causeserious or even fatal air embolism.

In Figs. 1 and 2, it will be seen that the body of the unit includespart 24 which is generally cylindrical and terminates in an'inner wall32 firmly secured to the outer face of the cannula 22. The side Wall ofcasing 24 is formed with openings 33; Its outer end convenientlyterminates in a tubular casing portion 34 adjacent the'inner end of thecannula 22 and an outwardly extending flange 36 at its free edge. Thisflange may define a fitting of the Luer type-which will permitconnection of body 24 with a syringe tip or other fiuicl-conductingunit.Masses of filtering material have been indicated at 37, one within theinner end of casing 24 and the other within portion 34. This materialmay embrace absorbent or nonabsorbent cotton which Will act as anelficient and adequate trap to filter out any bacteria suspended in airpassing through the venting structure. The amount of filtration varieswith the volume of air or gas to be passed, the rate of passage, etc.Various materials other than cotton may be employed such as, forexample, glass wool, fibre-glass or rock wool, mineral wool, such assteel and asbestos wool. Also, there may be used paper or othercellulose fiber or plastic material so fabricated as to allow bores ofadequately fine size such as porous plastic film, plastic or othersponge or foam forms. The material must of course lend itself to readysterilization.

Referring to Fig. 3, it will be seen that the numeral 38 identifies atubular body, the outer bore zone of which may be defined by an inwardlytapered passage 39 capable of receiving and having its surface grip atapered nozzle such as that of a syringe. It is furnished with openings40 adjacent its cannula end. The masses or plugs of filtering material37 are disposed one adjacent that end and the other adjacent the innerzone of the tapered portion 39. As a consequence of the flange whichdefines that zone, a shoulder or retaining portion is furnished whichprevents accidental dislodgement of the uppermost plug 37 in an outwarddirection.

In Fig. 4 a tubular body has been indicated at 41 and which has itsouter edge zone 4-2 extending inwardly into the bore to thus furnish aretaining part preventing dislodgement of the outer plug or mass 37.Body 41 is furnished with an annular series 'of ports 43 adjacent itsinner end. In line with these, the second plug of material 37 may bedisposed. In Fig. 5, body portions 44 and 45 are furnished and betweenwhich an indented part or groove 46 exists. Against the inner surface ofthe latter, the outermost plug 37 may hear. The inner plug is disposedadjacent the inner end wall of the structure and in a zone where thelatter is furnished with openings 47. Conveniently, body portion 44 mayhave extending from its outer face a head or flange 43. This willfurnish a retaining structure for any tube which may be ensleeved overthe body 44--45 for purposes hereinafter brought out.

As is well understood in the practice of medicine and in laboratorywork, receptacles of the type which require venting may be used in anupright or in an inverted position. The former has been shown in Fig. 1While the latter has been illustrated in Fig. 2. When employed inconnection with a flask having an inverted position, air must beadmitted to the interior of the latter to replace liquids such as blood,glucose, saline, amino acids, molar lactate solution, etc., etc. inadministration. Where, for example, gravity collection of blood is beingpracticed and the flask is in an upright position as in Fig. 1, the

- s aosasss r venting structure must allow the escape of gas such as airfrom the flask. Where the assembly is applied to a container under highvacuum, it must admit air without danger of the filtering materialpacking down and thus becoming inoperative. In the case of bloodcollection by gravity, should any blood or preservative solution beforced up through the cannula by the escaping displaced air, such liquidwould in the usual way wet the cotton or other filtering material andmake it substantially impenetrable to air. This, would also occur in thecase collection of blood which may be mixed with liquids such asacid-citrate-dextrose solution, or citrate, or chelating or other.anti-coagulantandpreservative solutions, or mixtures of such solutionswith blood. In the case of an inverted container with the latterconnected for intravenous, subcutaneous or other uses, liquid willfrequently flow down and moisten the bacterial filtering material. This,in effect, will also make the usual air vent inoperative. e

However, by having two areas of filtering material, one of which cannotbe contaminated or moistened by the fiask contents when upright, Whilethe other cannot be moistened with the container or flask in an invertedposition, it is apparent that under all circumstances an effectiveventing structure and bacterial filter is achieved. As in Fig. 2, liquidmay pass through the lumen of cannula 22; and into contact with thelower plug 37. However, the inner end of the cannula being disposedbetween the two filtering bodies, it is apparent that air will be freeto flow through ports 33 and the upper body of filtering material intothe lumen of the needle and discharge into the flask through opening 23.As in Fig. 1, any liquid flowing through this port into the lumen of thecannula 22 and out its upper end will deposit on the filtering body 37adjacent end wall 32 and will not destroy the effectiveness of thestructure. This will be because the plug of material 37 within portion34 will not receive the liquid thus discharged and'will therefore remainoperative.

The same is true of the structures embraced in the forms illustrated inFigs. 3, 4 and 5 in which, in each instance, the inner end of the needleis disposed intermediate the bodies or" filtering material. In commonwith the structure shown in Fig. 1, bodies 38, 41 and 44-45 may beprovided with an exterior indication such as 38. This may be in the formof indicia, colormarking, a flattened surface, etc. In any event itrelates the face of the outer end of the needle lumen to the externalsurface of the assembly. Accordingly, an operator may at all times knowthe direction in which the cannula opening is lying so that this openingmay be turned away from the inflowing blood or other fluid. This willavoid any probability of any sputtering, bubbling, or splashing liquidfrom entering the lumen of the structure when the receptacle is inupright position, by turning the openings in the cannulae of the ventingand the filling needle deg. away from one another. This will alsoprevent short circuiting in instances in which the inflow of material isvery rapid and the air or gas content of the receptacle is very quicklydisplaced. Under such conditions some degree of positive pressure may bebuilt up within the receptacle. Also, in the case of plastic or flexiblecontainers, air or gas currents can be set up in rapid filling. In suchcases incoming gas'or liquid, can by these currents, be deflected orshunted from the filling cannula opening to the venting structureopening with greater or lesser loss of material being introduced. This,as indicated above can largely be avoided by turning the openings of thecannulae away from one another.

Indentations, extensions, such as lateral bars, rings, or other devicesmay be added to the outside of the venting structure to give purchase orgrip and to act as shields to prevent the fingers from touching thestopper surface and to give greater bearing or gripping surface to forcethe cannula through the diaphragm and to later remove it.

As will be observed, the body of the unit is adequately long to providea sufiicient grip for the fingers when the cannula is being ttorcedthrough the diaphragm portion 18. In this manner, the fingers willremain spaced item the sterile'surface of the stopper as well as theouter wall of the cannula. It is apparent that in order to exertnegative or positive pressure to the interior of the con- .tainerthrough a venting structure such as the present, a section of tubing ofany proper material connected to the source of pressure or vacuum may beemployed. This tubing will simply be slipped over the exterior or bodies24, 38, 41 or 44-45 a sufficient distance to close the side wallopenings of the same. Where so disposed, flange 36 or bead 48 may assistin retaining the tubing from accidentally slipping over the bodies.Obiously, if it were desired not to ensleeve the tubing completelyoverThus among others, the several objects of the invention as specificallyaforenoted are-achieved. Obviously numerous changes in construction andrearrangements of .the parts might .be resorted to without departingfrom the 1 spirit of the invention as defined by the claims.

defined by a tubular end thereof, filtering material within such bodyadjacent said openings and said opposite needle end being disposed at aposition intermediate such open- 2. A venting structure including incombination a single cannula having a pointed closurepiercing end, atubular body, a wall at one end of said body and secured to said cannulawhereby the opposite end of the latter is surrounded by said body, theside wall of said body being formed with openings adjacent said endwall, a mass of filtering material disposed within such body adjacentsaid openings, .a second mass of filtering material within said body ata point opposite said end wall, said body being unobstructed at such endand said opposite needle end extending into a space existing betweensaid masses of filtering material.

3. A venting structure including a tubular body formed with openings inits side wall, a pointed cannula attached to one end of said body, amass of filtering material within said body and adjacent said cannula, asecond mass of filteringmaterial disposed adjacent the open end of thebodies, then the openings of the latter might be closed,

. in any desired manner.

said body and the masses of filtering material being separated with theinner end of said cannula extending into the space defining thatseparation.

References Cited in the file of this patent UNITED STATES PATENTS France..-..........'Mar. 3, 1954

